Insulin Therapy in the Hospital Comparing Two Protocols

Cook County Health

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: lispro insulin; Drug: NPH insulin and regular insulin; Drug: Glargine insulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00841919

BBJHS200901

Details and patient eligibility

About

The purpose of this study is to determine if by using insulin analog (Glargine and lispro insulin) with an insulin pen the investigators are able to obtain a higher rate of correct timing of insulin and food administration as when compared to the usual therapy (insulin NPH and regular) with syringes.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Uncontrolled blood sugar:

  • Random blood sugar ≥ 200mg/dl
  • Pre-prandial blood sugar greater than 180 mg/dl on two occasions within 24 hours.

• Patient may be off insulin or on subcutaneous inpatient insulin regimen less than 36 hours.

• Transition from an Insulin Drip in the intensive care units to subcutaneous insulin upon transfer to general ward.

• Patient is able to eat and oral feeding is expected.

Exclusion criteria

• Patients receiving inpatient oral hypoglycemic agents
• Patients with chronic kidney disease stages 4 & 5 (estimated GFR of <30ml/min) and on dialysis
• Patient with chronic liver disease
• Patient with hypoglycemia unawareness
• Pregnancy
• Patients who are on "NPO" for medical reasons.
• Patient is expected to stay in the hospital for less than 3 days.
• Patient on a new inpatient insulin regimen for > 36 hours.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

2

Active Comparator group

Description:

The active control group will receive twice daily NPH insulin as basal insulin and bolus (prandial) insulin as regular insulin to be administered 30 minutes before meals. The administration of basal (prandial) regular insulin and food will be done as the current usual care on the hospital ward. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix B. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff.

Treatment:

Drug: NPH insulin and regular insulin

1

Experimental group

Description:

The study group will receive Insulin Glargine as basal insulin and bolus (prandial) insulin as lispro insulin (choice between pens or vials will be made). The administration of bolus (prandial) insulin pen or syringe will be delivered concurrently with the food tray (the concept of "insulin pen/syringe on the food tray") by the nursing staff that together with hospital food services identifies the food tray for the patients in the study group. The protocol for initial insulin dose and subsequent dose adjustment has been developed by the "Inpatient Diabetes Advisory Group" and is detailed in appendix A. The patient will receive information regarding diabetes treatments, appropriate diet and diabetic self management which will be provided by the nursing and nutritional staff

Treatment:

Drug: Glargine insulin

Drug: lispro insulin